Re: Methodology for
Determining the Data Needed and the Types of Assessments Necessary to
Make FDCA Section 408 Safety Determinations for Lower Toxicity Pesticide
Chemicals

The Northwest Coalition
for Alternatives to Pesticides, the World Wildlife Fund, Beyond Pesticides
and the Natural Resources Defense Council submit the following comments
regarding the guidance document "Methodology for determining the
data needed and the types of assessments necessary to make FFDCA section
408 safety determinations for lower toxicity pesticide chemicals."

1. The proposed methodology
fails to implement the Food Quality Protection Act's mandates for EPA
to develop and implement an estrogenic substances screening program and
take action based on this screening "as is necessary to ensure the
protection of public health." [FFDCA Sec. 408(p)]

The Food Quality Protection
Act requires EPA to screen pesticide ingredients and determine their ability
to disrupt endocrine systems. EPA is also required to take action to protect
public health from those chemicals found to have endocrine effects. The
proposed methodology makes it virtually impossible for EPA to carry out
this mandate. The proposal exempts most "inert" and other "lower
toxicity" pesticide chemicals from additional data requirements.
Because few chemicals have existing data demonstrating whether or not
they affect endocrine systems, EPA will be left with no means to acquire
the information necessary to carry out this mandate.

We are particularly
concerned about the family of chemicals containing nonyl phenol, octyl
phenol, nonylphenol ethoxylates, and their chemical relatives. The World
Health Organization's International Programme on Chemical Safety has just
issued a report ("Global Assessment of the State-of-the-Science of
Endocrine Disruptors") that states that "numerous studies have
demonstrated the ability of NPEO's [nonylphenol ethoxylates] to disrupt
the normal function of the endocrine systems of various organisms."
As further evidence, we have attached to these comments a list of examples
of published research documenting these endocrine disrupting effects,
and studies that have been done to document the widespread environmental
contamination by these chemicals.

Many of this family
of compounds, however, have already been classified by EPA as List 4B
inerts (for example, p- nonylphenol, ethoxylated; nonylphenol, ethoxylated,
monoether with sulfuric acid; nonylphenol, ethoxylated, monoether with
sulfuric acid, sodium salt; nonylphenol, ethoxylated, monoether with sulfuric
acid, triethanolamine salt; nonylphenol, ethoxylated, phosphate ester;
4-nonylphenol, ethoxylated, phosphate ester; and nonylphenol, ethoxylated,
phosphate ester, sodium salt). Following the logic outlined in the guidance
document, an FFDCA Sec. 408 safety determination for these ingredients
will be made, and they will be exempted from the requirement of a tolerance,
all with little or no assessment of their endocrine disrupting potential.

2. The proposed methodology
fails to ensure that pesticide products will not cause "unreasonable
adverse effects on the environment" [FIFRA Sec. 3(c)(5)] and are
not "misbranded" [FIFRA Sec. 2, 12] because the proposed methodology's
reduced toxicology data requirements are not accompanied by requirements
for increased ingredient disclosure.

The Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) requires EPA to regulate pesticide
use "to the extent necessary to prevent unreasonable adverse effects
on the environment." FIFRA also prohibits the sale of misbranded
pesticides, those whose labels are false or misleading. In the agency's
regulations, EPA has specifically identified "a false or misleading
statement concerning the composition of the product" as an example
of misbranding.

Minimal toxicological
data requirements have been part of EPA's efforts to meet this FIFRA requirement
since the agency published its inert ingredients policy statement in 1987.
The proposed guidance document, however, states that "the 1987 base
set of data is no longer appropriate." This action destroys the balancing
act that has existed since 1987 between ingredient disclosure and toxicology
data requirements. Consumers are given neither the protection of toxicology
testing, or the information they need (ingredient disclosure) to conduct
their own hazard assessment. When EPA's Inert Disclosure Stakeholder Workgroup
surveyed how other agencies treat ingredient disclosure in other kinds
of consumer products, the Workgroup found that, in general, disclosure
requirements were imposed when toxicological data were not required. For
example, "while cosmetic producers are required to disclose every
ingredient of the cosmetic products they sell, they are not subject to
required toxicology studies or FDA review that would delay their entrance
to the market. In contrast, pesticide producers must make a significant
investment in toxicology and product chemistry and wait for EPA approval
before they can begin to produce a revenue stream from a new end-use pesticide
product." ["Final report of the Pesticide Program Dialog Committee
on the Activities of the Inert Disclosure Stakeholder Workgroup,"
April 2002.] The proposed guidance document reduces data requirements
for inert ingredients yet fails to improve labeling requirements.

It is worth noting
that the guidance document compares the agency's recommendation for reducing
data requirements for inert ingredients with the reduced data requirements
for biopesticides and antimicrobial pesticides. ("since biopesticides
generally tend to pose lower risks to humans than conventional pesticides,
the Agency generally requires much less data..."; "the data
requirements for each antimicrobial use category are commensurate with
the potential exposure and risks associated with that use pattern...")
However, in both of these cases (biopesticides and antimicrobials) the
ingredients that are the subject of the data requirements are identified
on product labels.

In conclusion, we
request that EPA include all inert ingredients in the prioritization process
for the Endocrine Disruptor Screening Program. Regulatory action to restrict
or eliminate toxic "inert" chemicals should not be delayed pending
this endocrine disruptor testing. We also request that inert ingredients
be identified on labels to the full extent possible under current law.

We look forward to
hearing how our comments will be incorporated into the final guidance
document.Sincerely,